Unknown / Not in EUDAMED

Snapshot 2026-10-09 · Link to EUDAMED

Invisalign First Intervals

UDI-DI 00816063023876Basic UDI-DI 081606302InvisalignMH

Class IIa · MDR · Align Technology Inc.

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Identification

Model: Invisalign System
EMDN: Q010499
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

3831212CE01

EU quality management system · unknown

Notified body: DEKRA Certification B.V. (0344)

Valid from 2026-07-02 · Expiry 2029-10-28

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Align Technology Inc.

SRN US-MF-000000744

US · San Jose

manufacturer

Authorised representative: Align Technology B.V. (NL-AR-000000061)

Related UDI-DIs

Invisalign ART 00816063023180
Invisalign Comprehensive Intervals 00816063023883
Invisalign First-Comprehensive 00816063020264
Invisalign First-Moderate 00816063020257
Invisalign Full 00816063020004
Invisalign Go 00816063020424
Invisalign Go 00816063020127
Invisalign Go Express 00816063021377
Invisalign Go Plus 00816063020431
Invisalign i7 00816063020073
Invisalign Lite 00816063020066
Invisalign System - Comprehensive 00816063020189

Showing 12 of 19 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/invisalign-first-intervals-3876 · UDI page: /udi/00816063023876

All devices from Align Technology Inc.

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